Human ARDSRE-CoV-ERYNCT04619368
Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19
An observational study of Human ARDS and Coronavirus Infection, run by University Hospital, Toulouse at 1 site in France.
Trial summary
For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human ARDS, Coronavirus Infection
- What is being tested?
- Follow up calls
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2020to 31 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cohort of all COVID patients who went out alive from intensive care
Who may be able to join
- adult patient
- hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery)
- intubated and ventilated
- supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio <300 mmHg)
- with an rt-PCR positive to SARS-CoV-2
- affiliated to the french social security
Who cannot join
- minor patient
- patient under protective measure
- ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)
For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.
The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).
Read the detailed description
Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain.
Beside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year.
The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.
- Conditions
- Human ARDS, Coronavirus Infection
- Being tested
- Follow up calls
- Keywords
- Post-intensive care Syndrome, Acute Respiratory Distress Syndrome, quality of life, intensive care unit, PTSD, follow-up after ICU, COVID-19
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections, postintensive care syndrome, Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up callsOther
The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
Measured: month 12
Secondary outcomes (12)
psychological disorders measured by QIDS
psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms
Measured: Month 3
psychological disorders measured by STAI-YA
psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety
Measured: Month 3
psychological disorders measured by QIDS
psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms
Measured: Month 6
psychological disorders measured by STAI-YA
psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety
Measured: Month 6
psychological disorders measured by QIDS
psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms
Measured: Month 12
psychological disorders measured by STAI-YA
psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety
Measured: Month 12
quality of life by EQL-5
Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life
Measured: Month 3
quality of life by EQL-5
Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life
Measured: Month 6
quality of life by EQL-5
Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life
Measured: Month 12
nutritional status
nutritional status measured by Nutritional Risk Screening 2002
Measured: Month 3
nutritional status
nutritional status measured by Nutritional Risk Screening 2002
Measured: Month 6
nutritional status
nutritional status measured by Nutritional Risk Screening 2002
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start27 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human ARDSStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny BOUNES, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619368
- Sponsor's protocol ID
- RC31/20/0219
- Acronym
- RE-CoV-ERY
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04619368
- Acronym / sponsor ID
- RE-CoV-ERY / RC31/20/0219
- Conditions
- Human ARDS, Coronavirus Infection
- Keywords
- Post-intensive care Syndrome, Acute Respiratory Distress Syndrome, quality of life, intensive care unit, PTSD, follow-up after ICU, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.
The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).
Detailed description
Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain.
Beside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year.
The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cohort of all COVID patients who went out alive from intensive care
Key inclusion criteria (6 listed)
- adult patient
- hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery)
- intubated and ventilated
- supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio <300 mmHg)
- with an rt-PCR positive to SARS-CoV-2
Key exclusion criteria (3 listed)
- minor patient
- patient under protective measure
- ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up callsThe follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit. | Other | – |
Primary outcome
Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
Time frame: month 12
Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
12 secondary outcomes
psychological disorders measured by QIDS
Time frame: Month 3
psychological disorders measured by STAI-YA
Time frame: Month 3
psychological disorders measured by QIDS
Time frame: Month 6
psychological disorders measured by STAI-YA
Time frame: Month 6
psychological disorders measured by QIDS
Time frame: Month 12
psychological disorders measured by STAI-YA
Time frame: Month 12
quality of life by EQL-5
Time frame: Month 3
quality of life by EQL-5
Time frame: Month 6
quality of life by EQL-5
Time frame: Month 12
nutritional status
Time frame: Month 3
nutritional status
Time frame: Month 6
nutritional status
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny BOUNES principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human ARDS and Coronavirus Infection, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.